Biostatistician Jobs

Department: Process Development

Report to: Director of Process and Product Development

Status: Full Time/ Exempt

Position Summary:

• Position will be located in Winston-Salem, NC
• Member of cross-functional teams who is effective in both independently and collaboratively in a flexible, fast-paced environment.
• Works closely and collaboratively with members of clinical, process development, quality, finance, and others to meet corporate goals.
• Contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions.
• Prepares statistical analysis plans, including table shells.
• Generates statistical models to improve methods of evaluating quantitative and qualitative data; identifying relationships and trends in data and factors affecting research results.
• Provides ad hoc data driven analyses.
• Automates data extraction and data preprocessing tasks.

Requirements:

• Advanced degree in Statistics, Biostatistics, Mathematics, or related field. PhD. preferred.
• Must have excellent interpersonal, communication, writing and organizational skills.
• Ability to evaluate moderately complex and variable issues with substantial potential impact, where development of an approach involves weighing various alternatives and balancing potentially conflicting situations using multiple sources of information.
• Ability to manage multiple work assignments and establish priorities for a diverse range of tasks.
• Flexibility to adapt quickly to the changing needs of the organization.
• Must have strong statistical academic background, knowledge of quantitative methods including predictive modeling techniques.
• Must have exceptional problem-solving and analytical abilities.
• Proficiency in SQL, JMP, SAS, R, Python or related data analysis languages required.
• Preference for previous experience with study design and data analysis from a range of different phases of clinical development.
• Possess an open-minded approach and tolerance in applying statistical methods when dealing with novel analyses.
• Must have excellent analytical skills in order to filter, prioritize and validate potentially complex and dynamic material from multiple sources.
• Minimum of 5 years of industry experience, including design and analysis of clinical studies (cell therapies/biologics a plus).

Qualified, interested candidates should send resume to: [email protected]